UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006832 |
|---|---|
| Receipt number | R000008085 |
| Scientific Title | Evaluation of time course hemostatic changes by ROTEM in pateints undergoing pediatric cardiac surgery |
| Date of disclosure of the study information | 2011/12/04 |
| Last modified on | 2015/04/08 13:57:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of time course hemostatic changes by ROTEM in pateints undergoing pediatric cardiac surgery
Acronym
ROTEM in pateints undergoing pediatric cardiac surgery
Scientific Title
Evaluation of time course hemostatic changes by ROTEM in pateints undergoing pediatric cardiac surgery
Scientific Title:Acronym
ROTEM in pateints undergoing pediatric cardiac surgery
Region
| Japan |
Condition
Condition
pediatric patients undergoing cardiac surgery
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether parameters obtained from pediatric patients undergoing cardiac surgery were related to patients outcome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
perioperative blood loss, transfusion
Key secondary outcomes
ICU stay
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
ROTEM group
Interventions/Control_2
Conventinal Group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
pediatric patients undergoing cardiac surgery
Key exclusion criteria
pediatric patients undergoing emergent cardiac surgery
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasufumi Nakajima |
Organization
Kyoto Prefectural University of Medicine
Division name
Dept of Anesthesiology
Zip code
Address
Kyoto, Japan
TEL
075-251-5633
nakajima@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasufumi Nakajima |
Organization
Kyoto Prefectural University of Medicine
Division name
Dept of Anesthesiology
Zip code
Address
Kawaramachi Hirokoji Kamigyo Kyoto
TEL
075-251-5633
Homepage URL
nakajima@koto.kpu-m.ac.jp
Sponsor or person
Institute
Dept of Anesthesiology
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Dept of Anesthesiology
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 15 | Day |
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 06 | Month | 30 | Day |
Other
Other related information
under investigation
Management information
Registered date
| 2011 | Year | 12 | Month | 04 | Day |
Last modified on
| 2015 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008085
